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Wednesday, November 27, 2013

23andMe's CEO letter and the FDA crisis

I just received this email from the 23andMe's CEO:

Dear 23andMe Customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers - but we recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don't have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Co-founder and CEO, 23andMe

I am a 23andMe customer. I was attracted to the genetic testing service because the results can be used for genealogical research, but have since grown to appreciate the health insights. In fact, family members have ordered kits based on the reports that they saw were available. We have already received the results for one relative, but two others are awaiting testing.

The other valuable service provided by 23andMe is the community. There are a lot of online discussions about genealogical and health results, and even more importantly, it's possible to reach out to people who share some common genes that indicate relative status.

I think the FDA should be concerned about the accuracy of the testing, and the potential for false positives. But remember that 23andMe is also focused on data quality. In addition, 23andMe is very careful to provide peer-reviewed research and other vetted data to users of its service, when it comes into providing health insights. It also states that health-related concerns should be discussed with doctors and other health professionals.

In other words, 23andMe is not a DIY diagnosis service. It shows risks based on genetic profiles and public research, and advises people to seek out professional medical advice.